Senior Regulatory Affairs Specialist
Sr. Regulatory Affairs SpecialistIn this role youLooking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.Your role:
Serve as RA Representative on project teams, develops regulatory submission strategies for new product launch, and provide regulatory guidance to the project teams.
Responsible for coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA, EU and other worldwide government agencies. Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability.
Negotiate and interact with regulatory authorities during the development and review process to ensure timely submission approval.
Maintain regulatory documentations to support compliance with regulatory requirements. Fulfills selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs and other documents.
You're the right fit if:
You’ve acquired 5+ years of experience in medical device regulatory or quality assurance field
Your skills include knowledge of quality system requirements and FDA and/or International product approval process, demonstrate a track record in obtaining FDA clearances and worldwide registrations, clinical trials and software development/regulatory submissions and authoring 510K’s. Experience with Software is a must.
You have a Bachelor’s degree in life sciences or a related field
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
How we work togetherWe believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.This is an office role.About PhilipsWe are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
Learn more about our business (https://www.philips.com/a-w/about.html) .
Discover our rich and exciting history. (https://www.philips.com/a-w/about/our-history.html)
Learn more about our purpose. (https://www.philips.com/a-w/about/environmental-social-governance/our-purpose)
Learn more about our commitment to diversity and inclusion (https://www.careers.philips.com/na/en/diversity-and-inclusion) .
Philips Transparency DetailsThe pay range for this position In MA, MN, WA, CA is $75,000 to $135,000, Annually. The pay range for FL is $75,000 to $125,,000.The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here (https://www.philipsusbenefits.com/) .At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.Additional InformationUS work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Cambridge MA, Orlando FL, Plymouth MN, San Diego CA, Bothell WA.#LI-PHIIt is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.Equal Employment and Opportunity Employer/Disabled/Veteran